WO2002024251A1

WO2002024251A1 - Treatment devices for medical, dental and veterinary services

Info

Publication number: WO2002024251A1
Application number: PCT/US2001/029500
Authority: WO
Inventors: Rhoda Zione
Original assignee: Rhoda Zione
Priority date: 2000-09-20
Filing date: 2001-09-20
Publication date: 2002-03-28
Also published as: AU2001294612A1; CA2460035A1

Abstract

Single unit, pre-filled, disposable, twist-top irrigation/lavage units are designed to reduce materials waste and enhance treatment and healing outcomes by preventing infections from fluid and equipment contamination and stimulating circulation. The multi-purpose catheters are designed to attach to syringes and irrigator/lavage units to enable access to small areas and tissue tunnels to flush out bacteria and drainage as well as to stimulate circulation for healing promotion. The manual fill irrigation/lavage syringe has the funnel attached to the needle port end of the syringe to offer the practitioner additional options and diversity in the irrigation, aspiration, and lavage regimens. Gravity flow disposable, single units with twist-tops at both ends are designed to enhance gravity flow. Irrigation, lavage, and gravity flow treatments are then enhanced by the design of 'kits' to enhance time management, reduce confusion, frustrations, and fostering paraprofessionals and patient's independent in managing these tedious and potentially messy regimens.

Description

Treatment Devices for Medical, Dental and Veterinary Services

1) Irrigator Devices with Medication Ports and Kits for Bladders and Bladder Catheters

2) Irrigator Devices with Medication Ports and Kits for Ears

3) Irrigator Devices with Medication Ports and Kits for Kidneys, Nephrostomy and Dialysis tubes

4) Irrigator Devices with Medication Ports and Kits for Surgical Lavage Treatments

5) Unit Fluid Devices (Gravity Flow) for Gastric and Naso-Gastric tubes or Other Gravity Flow Regimens and Kits

6) Multi-Procedural Catheters Device Types and Kits

DESCRIPTION

The present invention relates to medical devices for universal irrigation, lavage and gravity flow hydration therapies. The inventor, Rhoda Zione, noted that current irrigation, gravity flow hydration and lavage for medical, dental, and veterinary treatments administered by doctors and other professional and paraprofessional clinical/support staff are highly variable and subject to high rates of non-compliance in following prescribed therapeutic procedures and accepted medical or professionally related protocol. The inventor observed five problematic areas: 1) increased infections from the use of contaminated fluids such as normal saline and sterile water which were out dated, stored improperly, dispensed from non-sterile containers or contaminated in the mixing or reconstitution with various medications. Therefore, there appeared to be a need for a pre- filled unit with the prescribed volume plus a volume capacity of additional space e.g.... standard units: 1ml; 3 ml; 5ml; 10ml or more that allowed for medication additives to a single unit administration devices which is discarded after use. 2) the inventor noted that many procedures of medication application to the inner ear canal require irrigation of the ear prior to applying the medication to remove the drainage. This process requires an extensive collection of equipment, solutions, etc. that many nurses and practitioners will apply the medication without the properly irrigating the ear canal first. Therefore, because the drainage is not removed the medication is not fully absorbed and the healing process is remarkably impaired. Not only does enhance the treatment process, but it allows for the mixing of medication additives such as, e.g. hydrogen peroxide and normal saline in the irrigation units for a more therapeutic irrigation regimen. 3) the inventor noted increased risk of contamination of equipment such as containers and syringes used during irrigation procedures which compromise sterile applications and 4) the inventor noted the need for multiple items... e.g. cups, syringes, etc to complete the irrigation tasks. Often equipment used during procedures is dropped or engaged with contaminated fields. Therefore, when used, they introduce bacteria through the various portal tubes and create infections. 5) the inventor noted the inordinate amount of cost and revenue loss from product / material waste of normal saline and sterile water when containers with amounts larger than what is needed are used. For example, a doctor may order an irrigation gravity flow hydration and lavage treatment. It may require the use of 100 ml of fluid. The lowest amount /volume available for use is a 250 ml size. The 250 ml container is opened. 100 ml is used from the container and the rest is discarded. This practice costs tax payers billions of dollars per year. Additionally, when these devices are packaged in kits as taught by the present inventor, they facilitate the management of aseptic environments when used in surgery or other treatments where sterile technique and sterile equipment are indicated. 6) the inventor noted the need for multi-purpose irrigation and lavage catheters that have irrigation ports on all sides of the catheters and an open end design and ribbed side design to aide in the removal of dead/necrotic tissue while maintaining aseptic technique in procedures. These catheters are sterile and facilitate entry into cavities and orifices that are narrow but require thorough irrigation to remove drainage, tissue, and bacteria.

To address these needs, the inventor designed: 1) Single unit, hand-held, plastic /disposable irrigation and lavage systems or syringes which can be modified for blow-fill, cell-fill or similar technology, wherein a membrane separately or together, or valve, can be set to open or have a twist-off top to release the contained fluids such as normal saline or sterile water. When the top is removed, the administration port of the present irrigation can also be used as a medication port for in-filling medications such as antibiotics in a sterile manner with, for example, a needless syringe system. The single units of the present invention are designed with funnel ports with ribbed areas to allow for direct connection and fixation into catheter tubes. These single units for ear, bladder / kidney irrigation and lavage treatments would be manufactured in volume use in standard treatment protocols, for example: volume use many of which are identified in but not limited to these volume capacity units respectfully: 1) 3 ml 2) 5 ml 3) 15 ml ) 25 ml 4) 30 ml 5) 35 ml 6) 60 ml 7) 75 ml 8) 100 ml. These reflect volume measures that are standard to the industry for both pediatric and adult irrigation procedures, as well as those for dental and veterinary standards. Additionally, the units of the present inventions have additional space, for example, 10 ml to allow for medication additives. A 35 ml unit would have, for example, a space capacity for 45 - 47 ml of fluid in the unit. The units have graduated measurements on both sides, in opposite directions, which allows for a visual read of the exact amount of the liquid added or administered. It can also be used for wound irrigation in both human and animal patients. They also are packaged in sterile treatment kits with single or multiple units per kit. Gravity flow hydration units are similar in design to the forgoing irrigation systems. However, they have twist-off tops at both ends. The top end has an engagement funnel which allows for direct access to a naso-gastic tube (access through the nose into the stomach) or gastrostomy (access directly into the stomach through an opening / tube.) The bottom cap also twists-off to allow for air to flow into the device. Additionally, it can also be used as a medication or access port to add additional fluids, etc., into the "gravity flow system." When held erected vertically, these units allow for contained fluid to be administered into the tube by gravity flow.

If the bottom cap is not removed, the contained fluid can be administered into such tubes with pressure by squeezing the unit. This unit has significant value when fluid measures need to be assessed when caring for any patient. The present irrigation also facilitates patient independence for managing intake / hydration needs for water, sterile water, or normal saline when such tubes and fluids are indicated. The units also may be packaged in sterile kits with single or multiple units per kit.

Multi-purpose catheters are designed to attach to any irrigation unit or syringe with a tunneled attachment port. They are manufactured in materials which are conducive for their use. They are packaged in sterile treatment kits with single or multiple units per kit. Additionally, this application documents the novel and innovative use of the wound catheter as a multi-use irrigation and lavage device. The multiple design features of the present invention enhances the ability to access small, narrow areas in tissue structures. The ribbed and balloon designs of the present invention facilitate aid in the removal of dead tissue, drainage, and bacteria.

These present inventions enhance disease management strategies for 1) improving the efficiency of treatment regimens; 2) preventing infection and other complications; 3) reducing cost; 4) reducing material / supply waste; 5) enables and empowers patient's independence in self-care and therapeutic support for treatment regimens.

Irrigation and Lavage Systems and Syringes: Single unit, hand-held, plastic /disposable irrigation and lavage systems or syringes which can be modified for blow-fill, cell-fill or similar technology, wherein a membrane or the referenced membrane or valve can be set to open or have a twist-off top to release the contained fluids such as normal saline or sterile water. They also are designed with funnel ports ( long or short for use in ear irrigators ) with or with out ribbed areas of sufficient size to engage and affix inside tubes such as nephrostomy ( kidney), gastric, naso-gastric tubes or the external ear canal. These single units for the ear, bladder / kidney irrigation and lavage treatments are designed for unit measures of standard treatment regimens. They include but are not limited to units with a volume capacity sizes respectfully: 1) 3 ml 2) 5 ml 3) 15 ml ) 25 ml 4) 30 ml 5) 35 ml 6) 60 ml 7) 75 ml 8) 100 ml These reflect volume measures that are standard to the industry which include measures for both pediatric and adult irrigation procedures. The units would have additional volume space to allow for additives through the funnel ports of volumes beginning 1 ml and above. They have graduated measurements on both sides in opposite directions which allow for a visual read in upright or inverted positions of the exact amount administered. They also are packaged in sterile kits with single or multiple units per kit.

Gravity Flow Hydration Units: Gravity flow hydration units are similar in design to these irrigation systems modified for blow-fill, cell-fill or similar technology, wherein a membrane or the referenced membrane or valve can be set to open or have a twist-off top to release the contained fluids such as normal saline or sterile water. However, they also have twist-off tops at both ends. The top end has an engagement funnel which allows for direct access to a naso-gastic, gasostomy tube, or any other tube require gravity flow administration of the fluid. The bottom cap twist-off also to allow for air to flow into the device. When held erected vertically, these units allow for it's contained fluid to be administered into the tube by gravity flow. If the bottom cap is not removed, the contained fluid can be administered into such tubes with pressure by just squeezing the unit. This unit has significant value when fluid measures need to be assessed when caring for any patient using these types of treatment supports. It also facilitates patient independence for managing intake / hydration needs for water, sterile water, or normal saline when such tubes and fluids are indicated. They also are packaged in sterile kits with single or multiple units per kit.

Multi-purpose catheters are designed to be attached to any irrigation unit or syringe with a tunneled attachment port. They facilitate the irrigation of narrow areas in tissue structures. They are manufactured in materials which are conducive for their use and can be packaged in sterile kits

DESCRIPTION OF THE DRAWNINGS

Drawing 1.0 - Collapse Disposable Cell-Fill Irrigator / Lavage Type.

1.0 Illustrates the a twist-off top

1.2 Illustrates the funnel connection / medication additive port

1.4 Illustrates the spike access funnel. 1.6 Illustrates engagement

1.8 Illustrates fluid filled capsule

1 Λ 0 Illustrates the push plunger base

Drawing 2.0 - Syringe Cell-Fill Unit.

2.0 Illustrates the a twist-off top

2.4 Illustrates funnel connection / medication port

2.6 Illustrates spike funnel

2.8 Illustrates fluid filled capsule

2J0 Illustrates push plunger

Drawing 3.0 - Multiple Types - Irrigators / Lavage Units ( Ear, Bladder, Kidney etc.) ( A, B , C ,& D)

3.0 Illustrates twist-off top

3.2 Illustrates funnel connection with medication port

3.4 Illustrates the fluid chamber

3.6 Illustrates the graduated measurement in mis

3.8 Illustrates syringe irrigation attachment with or without ribbed areas

3.10 Illustrates syringe ear irrigation attachment

Drawing 4.0 - Irrigation / Lavage Multi-Purpose Catheters ( A, B, C, & D

4.0 Illustrates cannula tube.

4.2 Illustrate the irrigations port holes in tube

4.4 Illustrates ribbed area on tube 4.6 Illustrates ribbed and balloon

Drawing 5.0 - Syringe ( non-prefill / manual fill )

5.0 Illustrates funnel connection and medication port ( for ear or tube ) use

5.2 Illustrates ribbed area on funnel for connection to tubes

5.4 Illustrates barrel of syringe

5.6 Illustrates graduated measurements in ml

5.8 Illustrates plunger

Drawing 6.0 - Gravity Flow Unit

6.0 Illustrates twist-off cap

6.2 Illustrates funnel with or without ribbed area

6.4 Illustrates graduated measurements

6.6 Illustrates additive port for fluids, medications, and nutriments with twist off cap

Drawing 7.0 - Gravity Flow Unit Kit; packaged with or without gloves.

7.0 Illustrates gravity flow unit 7.2 Illustrates receptacle container 7.4 Illustrates sterile barrier

Drawing 8.0 - Irrigation Kits ( w/ attachments for tubes ); packaged with or without gloves.

8.0 Illustrates receptacle container 8.2 Illustrates 4x4 gauze pads

8.4 Illustrates alcohol pads

8.6 Illustrates sterile barrier

8.8 Illustrates irrigation unit ( one or more )

8J0 Illustrates irrigation catheter

8J2 Illustrates gloves

Drawing 9.0 - Surgical Lavage Unit Kit; packaged with or without gloves.

9.0 Illustrates receptacle container

9.2 Illustrates sterile barrier

9.4 Illustrates irrigation/lavage unit (s)

Drawing 10.0 - Ear Irrigator Kits; packaged with or without gloves.

10.0 Illustrates receptacle container

10.2 Illustrates 4 x 4 gauze (s)

10.4 Illustrates cotton swab (s)

10.6 Illustrates sterile barrier

10.8 Illustrates ear irrigator unit (s)

10.10 Illustrates gloves ( can be packaged with or without) DESCRIPTION OF THE PREFERRED EMBODIMENTS

The innovation of these devices afford a diverse range of uses in irrigation, lavage and gravity flow procedures in all clinical areas of medicine, dentistry, and veterinary sciences. The variation in size forges simplicity in treatment implementation because the fluid is contained in a single unit rather than having to gather multiple pieces of equipment and bottles of fluid to create a therapeutic irrigation regimen. This "single unit / pre-fill" design aids to prevent infection, reduce material costs, and enhance independence in patient self-care regimens.

Figures 1-A illustrates a blow-fill/cell fill pre-filled with irrigation/lavage fluid in a single unit. It's easy twist off top (1.0) and ribbed / spiked funnel (1.2 & 1.4) makes for easy use and quick engagement into tubes such as foley catheters or for single use in tissue irrigation or lavage. Its funnel (16 - 19 gauge) lumen aids in providing resistance such that when compressed it aids in irrigating with 4 - 15 PSI of pressure. The fluid cell (1.8) is designed to reinforce storage/packaging of the fluid. This device is desined also to enhance a therapeutic irrigation/ lavage regimen in treatments of such wounds as pressure ulcers.

Figure 2-A illustrates a blow-fill or cell-filled or similar technology syringe type. It's twist top (2.0), ribbed and spiked funnel(2.2 & 2.4), engagement seal (2.6), pre-filled with irrigation solution capsule (2.8)„ and push plunger (2J0), facilitates it use it the irrigation or lavage of tissue or irrigation of a variety of tubes. The cell fill unit of this device aids to prolonging storage of the unit and preventing leakage of the pre-filled cell before use. Figure 3-A,B,C,D, illustrates four different shapes of irrigators/lavage single, pre-filled units which have a twist off top (3.0), and funnel ( short or long ) (3.2)which is both the dispensing aperture and entrance port for medication additives. They fluid chambers (3.4) of the device hold the fluid and is easily dispensed through the funnel when compressed the contained fluid. All units have graduated measures (cc/ml) (3.6) indicated on the side. 3-A is a round type. The short funnel type for example can be used for ear irrigation. The long funnel type can be used for tube irrigation or tissue lavage. 3- B is a square type which aids in storing multiply units. 3-C is a collapsible type which can facilitate its use for people with small hands or for people with certain types of neuro-muscular impairment of the hands. 3-D is a trapeze type. It's degrading width is designed to aid gripping in people with small to moderate size hands. Figure 3-E illustrates disposable funnel tops, both short (3 JO) and long (3.8), that can be easily twisted onto a syringe or needle port to aid in lavaging or irrigating.

Figure 4 illustrates multi-purpose catheters for irrigation/lavage procedures. All catheters are designed in a cannula tube (4.0) formation have more than one opening (4.2) in the tip to facilitate irrigation in tissue tunnels or narrow passages. The catheters are designed for direct attachment to the long funnels of the irrigator/lavage units. Figure 4-A & B are smooth cannula catheters. Figure 4 - C has ribbed area (4.4) on one side of the catheter to aid in removing dead tissue, mucous, or drainage. Figure 4 - D has a balloon aperture (4.6) at the tip with a ribbed structures (4.4) to aid in irrigating / lavaging necrotic tissue areas.

Figure 5-A is a manual fill system syringe unit designed with or without a ribbed funnel (5.0 & 5.2) and a removable plunger (5.80). The plunger is used to aspirate fluid into and expel from the barrel (5.4) of the unit. The graduated measurement indicators (5.6) on the side are use to measure specific amounts for application. The funnel facilitates its attachment to any tube for an irrigation procedure or to direct the stream of fluid in a lavage treatment.

Figure 6-A & B are gravity flow units are designed with twist-off caps (6.0), with or without ribbed funnel apertures (6.2), additive port (6.6) and are pre-filled with fluid. They have graduated measurements (6.4) on the sides and twist off caps at both ends. These units are design to aid in such ( but not limited to ) feeding regimens using naso-gastric or gastric tubes or bladder irrigations. The twist cap to the funnel aperture is removed so it can be attached to the feeding or Foley bladder catheter and then the other twist cap at the opposite end (round cap) is removed so that the fluid can run in to the tube ( gravity flow) and other fluids and medications can be added.

Figure 7 illustrates a gravity flow unit kit. The items of the kit (gravity flow unit (7.0), receptacle (7.2), sterile barrier (7.4) are organized in a kit to facilitate the feeding or irrigation procedure; prevent contamination of equipment; and control waste and spills of gastric fluids/content.

Figure 8 illustrates the tube irrigator kits. Its contents are organized to facilitate the irrigation / lavage of such procedures as the care of a complex wounds with tunnels and undermining. The kit contains a receptacle (8.0), gauze (8.2), and alcohol pad (8.4) for cleansing of the tube (to be entered) sterile barrier (8.6), irrigator / lavage unit (s) (8.8), irrigation catheter (8J0), and gloves (8J2).

Figure 9 illustrates a lavage kit for use in lavaging tissue. The kit contains: a receptacle with or without a tube notch (9.0); a sterile barrier (9.2); and an irrigator unit (9.4). Figure 10 illustrates an ear irrigation kit. Each kit contains: a receptacle with or without a tube notch (10.0); gauze (10.2), cotton tip swabs (10.4); a sterile barrier (10.6); an irrigator unit (10.8) and gloves (10.10) optional.

Claims

CLAIMSI claim:

1. A modified irrigation / lavage single unit device, comprising:

a disposable device for packaging and dispensing fluids having a length, a width, and a

thickness of sufficient dimensions to contain a twist-off top, short or long funnel /port aperture,

and fluid in a compressible fluid chamber, whereby material waste can be reduced, contamination

and infection prevented, and treatment regimens improved by using single unit irrigation / lavage

devices.

2. The modified irrigation / lavage of claim 1, wherein the long funnel aperture having a

length, a width, a thickness of sufficient dimension with optional ribbed structure (s) and a cone

shape sufficient to create resistance the fluid can be dispensed with pressure when the fluid

chamber is compressed and additives such as medication can be put into the device.

3. The modified irrigation / lavage of claim 1, wherein the long funnel aperture having a

length, a width, a thickness of sufficient dimensions for direct connection to tubes to facilitate

tubal and other irrigation/lavage procedures.

4. The modified irrigation / lavage of claim 1, wherein the short funnel aperture having a

length, a width, a thickness of sufficient dimension with optional ribbed structure (s)

and a short wide cone shape sufficient to facilitate irrigation / lavage of small canals and orifices such as ears.

5. The modified irrigation / lavage of claim 1, wherein the fluid chamber apparatus with graduate measures on the side and shape selected from the group consisting of a round barrel, a square barrel, a collapsible/multi-level barrel, and triangular barrel.

6. A syringe irrigation / lavage funnel device, comprising:

A disposable, multi-size device with dimensions sufficient enough to attach to any size syringe or needle port and having the length and width dimensions sufficient, whereby small as well as large tissue areas are irrigated / lavaged to enhance the healing process.

7. A modified catheter canula, comprising:

A disposable catheter canula having a length, a width, a thickness and apertures of sufficient dimensions to dispense fluids and attach to syringes and irrigation / lavage devices, whereby enhancing irrigation and lavage treatments.

8. The modified catheter canula of claim 6, wherein the insert tip of the catheter has round apertures and optional ribbed surfaces sufficient to enhance the access of small tissue areas for removal of necrotic tissue and exudate to promote vascular stimulation and healing.

9. A modified syringe, comprising: a disposable syringe having a length, a width, a thickness of sufficient dimensions to contain a funnel aperture, a fluid barrel with graduated measurements, and removable plunger, whereby irrigation/lavage procedures for can be enhanced.

10. The modified syringe of claim 8, wherein the funnel aperture is affixed at the needle port of the syringe having a length, a width and a thickness with or without ribbed structures of sufficient dimensions to engage tubes and create resistance for pressurized application of fluid when the plunger is compressed.

11. A modified fluid packaging device, comprising:

a disposable, single unit device for packaging and dispensing fluids having a length, a width, and a thickness of sufficient dimensions to contain a twist-off top at both ends, a funnel aperture, additive port aperture, and fluid in a compressible fluid chamber with graduated measurements for gravity flow regimens such as those for treatments, hydration, nutrition and medication regimens, whereby material waste can be reduced, fluid contamination and infection prevented, and treatment, hydration, nutrition and medication regimens enhanced.

12. The modified fluid packaging device of claim 10, wherein apertures are at both ends. At one end, has a funnel aperture with ribbed structure (s) (optional) and a twist-off top having a length, a width, a thickness of sufficient dimensions to engage a tube for gravity flow regimens such as those for gastric feedings or direct fluid dispensing, At the other end, an additive port aperture with a twist top having a length, a width, a thickness of sufficient dimensions to allow for adding fluids such as medications, water and nutriments for regimens such as tubal feedings.

13. A kit for fluid packaging devices (gravity flow units), comprising: a systematic method of organizing disposable items to enhance gravity flow treatment regimens, wherein a receptacle having a length, a width and a thickness of sufficient dimensions to contain tissue and materials waste for disposal from the gravity flow procedure contains one or more fluid packaging devices (gravity flow units) with twist-top apertures at each end, and a sterile barrier to create an aseptic field on which to organize the kit items and perform the treatment regimen.

14. A modified kit for irrigation/lavage devices with catheters, comprising:

a systematic method of organizing disposable items to enhance irrigation / lavage treatment regimens with a catheter, wherein a receptacle having a length, a width and a thickness of sufficient dimensions to contain tissue and materials waste for disposal from the irrigation / lavage procedure (s) contains gauze for skin/tissue cleansing, anti-bacteria or anti-microbial cleanser for cleaning tube for access, a sterile barrier for creating an aseptic field for organizing and performing the procedure, one or more irrigator disposable units, an irrigation catheter (optional) and gloves (optional).

15. A modified kit for lavage devices, comprising: a systematic method of organizing disposable items to enhance lavage treatment regimens, wherein a receptacle having a length, a width and a thickness of sufficient dimensions to contain tissue and materials waste for disposal from the lavage procedure (s) contains a sterile barrier for creating an aseptic field for organizing and performing the procedure, and one or more irrigator

disposable units.

16. A kit for ear irrigation/lavage devices, comprising:

a systematic method of organizing disposable items to enhance ear irrigation / lavage treatment regimens, wherein a receptacle having a length, a width and a thickness of sufficient dimensions to contain tissue and materials waste for disposal from the ear irrigation / lavage procedure (s) contains gauze for skin/tissue cleansing, cotton-tip swap, a sterile barrier for creating an aseptic field for organizing and performing the procedure, one or more ear irrigator disposable units, and gloves (optional).